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Primadry Product Line

by Ultradent Products, Inc.

510(k) K931868

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K931868↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK931868 Date22 Jul 1993ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
EBC
Device class
Class II
Regulation
21 CFR Part 872.3765
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Primadry Product Line is a Pit and Fissure Sealant, Conditioner, and Drying Agent designed to prevent microleakage and improve retention of dental sealants. It functions by rapidly volatilizing residual moisture in tooth pits and fissures, ensuring a dry surface for optimal sealant application. This product is specifically formulated to enhance the effectiveness of hydrophobic sealants by eliminating trapped moisture that could compromise adhesion.

Primadry is supplied as a liquid drying agent containing 99% organic solvents and 1% primer, intended for use in dental settings. It is applied after rinsing with water and air drying, ensuring complete moisture removal prior to sealant placement. The product is single-use, non-sterile, and classified as Class II under FDA regulations. Authorized under FDA 510(k) clearance (K931868) and EU MDR compliance, it adheres to dental industry standards for pit and fissure treatment.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Primadry Product Line in dental procedures?

    The Primadry Product Line is designed to prevent microleakage and improve the retention of dental sealants by rapidly removing residual moisture from tooth pits and fissures. This ensures a dry surface, which is critical for optimal adhesion of hydrophobic sealants, ultimately enhancing their effectiveness.

  • How is the Primadry Product Line supplied, and is it intended for single-use?

    Primadry is supplied as a liquid drying agent in a formulation containing 99% organic solvents and 1% primer. It is explicitly labeled as single-use, meaning each bottle is intended for one application before disposal. This design aligns with standard dental practice for maintaining sterility and hygiene.

  • Is the Primadry Product Line sterile, and what storage considerations should be taken into account?

    The Primadry Product Line is non-sterile, so it should not be considered for direct patient contact without additional sterilization or preparation. Since it is a liquid, it should be stored in a cool, dry place away from direct sunlight, as organic solvents can degrade with heat or light exposure. Always check the label for specific storage instructions.

  • What regulatory pathways has the Primadry Product Line followed for approval, and what does this mean for clinicians?

    The Primadry Product Line has undergone FDA 510(k) clearance (K931868) and complies with EU MDR (Medical Device Regulation) standards. This means it has been evaluated by regulatory authorities to demonstrate substantial equivalence to legally marketed devices in the U.S. and meets EU safety, performance, and clinical requirements. Clinicians can rely on its compliance with these frameworks as part of their decision-making process.

  • Are there different sizes or models available for the Primadry Product Line, and how should they be selected?

    The provided data does not specify distinct sizes or models for the Primadry Product Line, but it is classified under OpenFDA as a Pit and Fissure Sealant, Conditioner, and Drying Agent with multiple registration numbers, suggesting it may be available in standard bottle sizes typical for dental drying agents. Selection should align with practice volume and workflow, but no unique clinical variations (e.g., pediatric vs. adult) are mentioned in the data.